Vicore Receives FDA Breakthrough Device Designation for AlmeeTM: A Digital Therapy Aimed at Treating Patients with Pulmonary Fibrosis
Wednesday, March 20, 2024
Vicore Pharma Holding AB (publ) has achieved a significant milestone in medical innovation with its breakthrough therapy, AlmeeTM. This digital cognitive behavioral therapy (CBT), designed to address anxiety symptoms associated with pulmonary fibrosis (PF), has been granted FDA Breakthrough Device Designation status. This designation signifies the potential of Almee to provide a more effective treatment option for individuals grappling with life-threatening or debilitating diseases like PF.
Almee stands out as a patient-centric solution based on CBT principles, accessible through smartphones or tablets. The recent COMPANION study showcased its efficacy, revealing notable improvements in both the generalized anxiety disorder scale (GAD-7) and quality of life measured by the King's Brief Interstitial Lung Disease (KBILD) total score.
Pulmonary fibrosis affects a significant portion of the population, with its incidence on the rise. Current therapies primarily focus on slowing disease progression, leaving a gap in addressing the psychological toll experienced by patients. Almee's breakthrough designation underscores its potential to alleviate anxiety, thus enhancing the overall quality of life for individuals battling PF.
Ahmed Mousa, Chief Executive Officer of Vicore, expressed his enthusiasm for this achievement, highlighting Almee's promise in improving the lives of PF patients. Vicore aims to showcase Almee and the compelling COMPANION study findings at an upcoming pulmonology conference in 2024.
In its pursuit of advancing Almee, Vicore seeks collaboration with developers of approved and late-stage molecular therapies for PF treatment. Dr. Jessica Shull, Director of Digital Health at Vicore, emphasized Almee's significance as a pioneering example of integrating digital and molecular therapies to deliver impactful patient outcomes.
Almee's development and regulatory journey are conducted in partnership with Alex Therapeutics, positioning it as a beacon of innovation in the evolving landscape of healthcare.
Source: vicorepharma.com
